Europe – Monkeypox: EMA starts review for Imvanex
EMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people...
UK – G7 health ministers unite to protect world from another pandemic
Commitments also made on tackling antimicrobial resistance (AMR) – a global killer costing millions of lives a year
Focus on climate and health...
UK – UK to introduce new regulatory framework for point of care manufacturing
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality...
USA – Legal expert: FDA inspections will start looking at DSCSA compliance
Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
Europe – ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for...
EMA’s Emergency Task Force (ETF) considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for primary...
USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
USA – FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance offering examples of how drug sponsors can rely on generally accepted scientific...
Europe – EU agencies adopt workplan on AI in medicines regulation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a workplan to facilitate the “responsible and beneficial” use of...
